D8488C00001: A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent platinum resistant epithelial ovarian cancer, including fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation (IRB#46425)

Cancer Type

Ovary

Study Summary

This study focuses on patients with ovarian cancer who do not have a harmful mutation in their BRCA1 or BRCA2 genes, have received at least three prior chemotherapies, and whose cancer returned within six months of the last dose of chemotherapy that included either cisplatin or carboplatin. The purpose of the study is to determine whether the combination of two experimental drugs, cediranib and olaparib, is effective and tolerable in these patients. Participants should have received prior antiangiogenic treatment (e.g., bevacizumab) within six weeks before starting treatment.

Cediranib works by slowing or stopping the growth of new blood vessels in the cancer, which makes it more difficult for nutrients and oxygen to reach the tumor. Olaparib is an inhibitor of poly denosine diphosphate-ribose polymerase (PARP). It is hoped that inhibiting PARP with olaparib will prevent cancer cells from repairing their DNA, causing the cancer cells to shrink or die.

Researchers test an experimental drug or treatment in a small group of people (20-80), to evaluate its safety and identify side effects. Often these trials are not disease specific and may include more than one type of cancer.

The experimental drug or treatment is administered to a larger group of people (100-300) to determine its effectiveness and to further evaluate its safety.

The experimental drug or treatment is administered to larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatment, and collect information that will allow the experimental drug or treatment to be used safely.